MOLOGEN AG Jefferies 2014 London Healthcare Conference

Transcription

1 Jefferies 2014 London Healthcare Conference Dr. Matthias Schroff Chief Executive Officer London 20 November 2014

2 V1-6 Disclaimer Certain statements in this presentation contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this presentation regarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forwardlooking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication

3 Agenda Business overview MGN1703 cancer immune therapy MGN1601 therapeutic vaccination against cancer EnanDIM - new generation of immunomodulators Key financials and summary

4 Company overview Biotechnology company pioneering in cancer immuno-therapies and DNA vaccines Two unique proprietary lead products MGN1703 DNA immunomodulator MGN1601 therapeutic vaccination Solid financing and cash inflow from capital increase in February

5 MOLOGEN: Pioneering cancer immune therapies MGN1703 MGN1601 Immunomodulator and TLR-9 agonist Colorectal cancer (mcrc) Small Cell Lung Cancer (SCLC) Therapeutic cancer vaccination Renal cancer Other solid tumors Other solid tumors Proof of efficacy (mcrc) Superior safety and tolerability Currently, two trials ongoing: 1. IMPALA: pivotal Phase III in mcrc ASET: Successful study phase I/II completed Superior safety and tolerability Promising overall survival data 2. IMPULSE randomized in SCLC

6 MGN1703 Cancer immunotherapies: New megatrend Science Magazine: Breakthrough of the Year 2013 Cancer immunotherapy is the use of the immune system or components of it to treat cancer

7 MGN1703 MGN1703: Best in Class TLR-9 Agonist No open ends - protection against degradation Only natural DNA components No chemical modifications High stability Broad activation of the immune system Only minimal side effects No dose-limiting toxicity High dosing over long periods of time Light blue area : recognized by TLR-9 receptor

8 MGN1703 Activate the immune system to fight cancer pdc plasmacytoid dendritic cell mdc myeloid dendritic cell NK cell natural killer cell NKT cell natural killer T cell

9 MGN1703 IMPACT phase II study in colorectal cancer: Outstanding long-term responses Primary endpoint met: Progression Free Survival (Hazard ratio: 0.55; p=0.04) Follow-up of four patients who continued MGN1703 treatment in compassionate use programs since no relapse at end of study: Three patients progression free in excess of months as of April 2014 Excellent safety and tolerability, also when treated long-term Secondary endpoint overall survival : results are not yet mature Predictive biomarkers identified: CEA level, tumor reduction by induction therapy, activated NKTs Findings from subgroup analyses used to optimize the IMPALA study design CEA carcinoembryonic antigen - a tumor marker for colorectal cancer NKT Natural Killer T cells

10 MGN1703 IMPALA: Pivotal study started in September 2014 Standard first-line chemotherapy for mcrc Trial Treatment Period Maintenance Re-Induction Induction CT weeks PR/CR Responder Screening/ Randomization 1:1 MGN1703 PD MGN1703 with induction CT PD Start of 2 nd line Control group PD Induction CT PD Primary endpoint: OS Secondary endpoints: e.g. progression-free survival, QoL, toxicity and safety Open-label, randomized controlled two-arm, multinational phase III trial 540 patients with metastatic colorectal cancer in more than 100 sites in eight European countries, including Top 5 European pharma markets mcrc metastatic colorectal cancer CT chemotherapy PR partial response CR complete response PD progressive disease OS overall survival QoL quality of life

11 MGN1703 IMPULSE study started in March 2014 Standard first-line chemotherapy for Extensive Disease SCLC Trial Treatment Period Maintenance Induction CT 4 cycles of platinum-based therapy PR/CR Responder Screening/ Randomization 3:2 Experimental arm: 5th cycle of platinum based CT followed by MGN1703 maintenance PD Start of 2 nd line Control group: 5th cycle of platinum based CT followed by local practice PD Primary endpoint: OS Secondary endpoint: progression-free survival Randomized controlled two-arm, multinational trial with 100 patients with extensive disease small cell lung cancer in Belgium, Austria, Germany and Spain Biomarkers are used as stratification factors: NSE levels and NKTs SCLC small cell lung cancer NSE neuron specific enolase - a tumor marker for lung cancer NKT Natural Killer T cells CT chemotherapy PR partial response CR complete response OS overall survival PD progressive disease

12 MGN1703 MGN1703: Successful safety trial in the U.S. Placebo-controlled, double-blind phase I study in healthy volunteers Favorable safety, tolerability and pharmacokinetic profile Consistent immune activation Investigational New Drug (IND) application approved by FDA for MGN1703 in solid tumors IND enables inclusion of the U.S. in the future MGN1703 development program FDA US Food and Drug Administration

13 MGN1703 MGN1703 Milestones Metastatic Colorectal Cancer (mcrc) IMPALA (Phase III trial) First patient in, PEP: OS IMPACT (Phase II trial) OS data expected IMPALA Recruitment completed IMPALA Primary analyses (OS), Filing/Approval / 2018 IMPULSE (randomized, controlled trial) First patient in, PEP: OS IMPULSE Recruitment completed IMPULSE Primary analyses (OS) Small Cell Lung Cancer (SCLC) PEP primary endpoint OS overall survival

14 MGN1601 Therapeutic vaccination against cancer MGN1601 Orphan Drug Status in EU

15 MGN1601 ASET: Promising data from renal cancer trial with tumor vaccine MGN1601 Final data set from ASET phase I/II study presented at scientific conferences in H1 2014: Primary endpoint met: Favorable safety and tolerability profile Promising overall survival data in subgroup of patients Identification of potential biomarkers Orphan Drug designation from EMA EMA European Medicines Agency

16 EnanDIM EnanDIM: New generation of immunomodulators Combining advantages of two types of TLR-9 agonists Broad immune activation shown in pre-clinical trials Potential application in the fields of cancer and anti-infective therapies MGN1703 Linear DNA-structure Closed, dumbbell-shaped structure Only natural DNA components Good safety and tolerability profile One additional production step Linear molecules Easy and cost-effective production Chemically modified structure ( ) EnanDIM = Enantiomeric DNA-based ImmunoModulator Linear molecules No chemical modifications Good safety and tolerability profile expected Easy and cost-effective production DNA sequence essential for function (so-called CG motifs ) New structural feature Protection against degradation

17 Key financials 9M 2014: Strong cash inflow from capital increase [in million] Sep Dec Cash & cash equiv % Balance sheet total % Balance sheet dominated by cash inflow from capital increase of around 16m Equity ratio 86% 94% -9% [in million] 9M M 2013 R&D expenses % EBIT % Cash flow from operating activities % Cash flow from financing activities % Monthly cash burn % Preparation of IMPALA and start of IMPULSE studies main drivers of increased R&D costs Monthly cash burn increased accordingly CF from financing activities includes capital increase

18 Lead products: Unique profile and huge market potential MGN1703 MGN1601 First-line maintenance Long-term treatment Usable for various indications Blockbuster Potential Superior safety and tolerability Suitable for mono- and combination therapy Patient selection via biomarker

19 Corporate calendar and contact details March 25, 2015 Financial Year 2014 May 12, 2015 Quarterly Report as of March 31, 2015 August 13, 2015 Quarterly Report as of June 30, 2015 November 12, 2015 Quarterly Report as of September 30, 2015 Claudia Nickolaus Head of IR & Communications Phone: Fax: MOLOGEN, MIDGE, dslim, and EnanDIM are registered trademarks of the 18

20 APPENDIX

21 Advanced product pipeline with strong focus on cancer immune therapies Pre-clinic Phase I Phase II Phase III/ Approval EnanDIM Oncology & Anti-infectives MGN Other solid tumors MGN Small cell lung cancer MGN Colorectal cancer MGN1331 Leishmaniasis MGN1601 Renal cancer MGN1333 Hepatitis B MGN Malignant melanoma Oncology Infectious diseases Oncology & Infectious diseases 1 IND (Investigational New Drug) filed in U.S.; safety trial in U.S. completed 2 Collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin

22 IMPACT study design Induction CT months Trial Treatment Period Maintenance mcrc patients treated first-line with FOLFOX/ XELOX or FOLFIRI +/- Bevacizumab* * at investigators discretion At least SD Screening/ Randomization 1:1 Experimental arm: 60mg MGN1703 twice weekly s.c. No maintenance Placebo twice weekly s.c. PD ** PD ** ** Treatment after PD at investigators discretion Primary endpoint met: PFS Secondary endpoint: OS Double-blind, randomized, placebo-controlled, two-arm, multinational phase II trial in 59 patients with mcrc from six European countries Predictive biomarkers identified: CEA level, tumor reduction by induction therapy, activated NKTs Start: June 2010 primary completion date: February 2013 CT chemotherapy SD stable disease PD progressive disease s.c. subcutaneous injection OS overall survival CEA carcinoembryonic antigen - a tumor marker for colorectal cancer NKT Natural Killer T cells mcrc metastatic colorectal cancer PFS progression free survival

23 ASET study design Trial Treatment Period Treatment per protocol (TPP) Extension phase Patients with advanced renal cell cancer No standard therapy available Trial inclusion 8 applications of MGN1601 in 12 weeks i.d. Disease Control Max. 5 applications in week 24, 36, 48, 72, and 120 PD** PD** ** Treatment after PD at investigators discretion Primary endpoints met: safety and tolerability Open-label, proof-of-principle, multi-center phase I/II trial 19 patients with advanced renal cell carcinoma who failed prior systemic therapies Orphan drug designation from EMA Start: December 2010 primary completion date: August 2013 PD progressive disease i.d. intradermal injection EMA European Medicines Agency

24 MOLOGEN shares ISIN DE Shares issued: 16,973,626 Max. 1.6 million share options (employee stock option plans) Frankfurt Stock Exchange (Prime Standard): MGN Reuters: MGNG.DE Distribution of shares (estimates) Free float 53% Private investor, Germany 24% Deutscher Ring Krankenversicherungsverein a.g., Germany 8% Baloise Holding, Switzerland 8% Salvator Vermoegensverwaltungs GmbH, Germany 7%